POS1060 CHANGES IN DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH IXEKIZUMAB IN A REAL-WORLD US COHORT
Authors: J. Birt, W. Tillett, C. Cavanaugh, Y. Jung, A. Vadhariya, S. Ross, J. Paulus, A. T. Sprabery, E. Lubrano
Journal: Annals of the Rheumatic Diseases (2022)

Background Ixekizumab (IXE), an IL-17A inhibitor, has demonstrated efficacy in clinical trials 1-3 but real-world effectiveness (RWE) data are limited. 4 Objectives To describe changes in disease activity and patient-reported outcomes (PROs) at 6 and 12 months follow-up among psoriatic arthritis (PsA) patients initiating IXE in a routine clinical setting. Methods This retrospective cohort study included patients from the OM1 PsA Registry (OM1, Boston, MA), a linked electronic medical record and administrative claims dataset with over 50,000 patients. Eligible patients had ≥1 prescription for IXE (first = index), were ≥18 years old at index, had ≥1 diagnosis code for PsA in the 12 months before or on index, and had ≥12 months of baseline and ≥6 months of follow-up data as of June 2021. For patients with baseline and follow-up measures available, changes in Clinical Disease Activity Index (CDAI), PROs, and other clinical outcomes from baseline to 6 and 12 months were described. For patients on IXE monotherapy, change in CDAI score from baseline to 6 and 12 months was assessed using mixed effects linear models adjusted for age, sex, and baseline CDAI score. Results The study population included 1,812 patients with a mean age of 53.7 years (Table 1). Psoriasis was present in 82% and enthesitis in 28%. Over 60% of patients were obese, and the mean Charlson Comorbidity Index was 1.3. Most patients (84%) had prior treatment with a biologic disease-modifying antirheumatic drug (bDMARD) and 40% with a targeted synthetic DMARD (tsDMARD). The mean number of bDMARDs and tsDMARDs used during all available prior history was 2.3 and 1.1, respectively. The most common prior bDMARDs were secukinumab (n=428, 24%) and adalimumab (n=245, 14%). Table 1. Demographic and Clinical Characteristics by Therapy Status All Patients(N=1,812 ) Monotherapy(N=1,485 ) Combination Therapy(N=327 ) Age (years) Mean (s.d.) 53.7 (12.2) 53.9 (12.3) 52.9 (11.7) Median (Q1-Q3) 55 (46-62) 55 (46-62) 54 (45-61) Sex Female 1,108 (61.1%) 909 (61.2%) 199 (60.9%) Male 704 (38.9%) 576 (38.8%) 128 (39.1%) Charlson Comorbidity Index Mean (s.d.) 1.3 (1.6) 1.3 (1.6) 1.5 (1.7) Median (Q1-Q3) 1 (0-2) 1 (0-2) 1 (0-2) BMI Underweight: &lt;18.5 10 (0.6%) 10 (0.7%) 0 (0.0%) Normal weight: 18.5-24.9 210 (12.2%) 172 (12.2%) 38 (12.1%) Overweight: 25-29.9 455 (26.5%) 379 (27.0%) 76 (24.2%) Obese: &gt;= 30 1,045 (60.8%) 845 (60.1%) 200 (63.7%) Missing 92 79 13 Domains of PsA: Psoriasis Yes 1,490 (82.2%) 1,222 (82.3%) 268 (82.0%) No 322 (17.8%) 263 (17.7%) 59 (18.0%) Domains of PsA: Enthesitis Yes 510 (28.1%) 409 (27.5%) 101 (30.9%) No 1,302 (71.9%) 1,076 (72.5%) 226 (69.1%) Of patients with a baseline CDAI score, 61% had moderate or severe disease activity. For all patients, CDAI scores improved (decreased) by an average of 3.4 and 3.7 points at 6 and 12 months, respectively, from a baseline mean of 15.4. All disease activity measures and PROs improved from baseline to 6 and 12 months (Figure 1). In patients persistent with IXE, 35.3% and 33.7% were in CDAI remission or low disease activity at 6 and 12 months after initiation, respectively. For IXE monotherapy users (82% of patients), at baseline, patients had a mean CDAI of 14.3 (n=131) and 15.1 (n=105) for the 6 and 12 month analyses, respectively. Adjusted mean changes in CDAI from baseline to 6 months (-3.6 points, p &lt; 0.0001) and 12 months (-4.9 points, p &lt; 0.0001) were statistically significant. Conclusion In this cohort of PsA patients with multiple prior b/tsDMARD failures, improvements in disease activity and PROs were observed at 6 and 12 months after initiating treatment with IXE. Improvements were observed in patients overall and in the monotherapy subgroup. More real-world research on IXE and other bDMARDs are important to understand the effect of treatment choices on clinical and PROs in both bDMARD-naive and experienced PsA patients. References [1]Mease PJ. Ann. Rheum. Dis. 2017;76(1):79-87 [2]Nash P. Lancet . 2017;389(10086):2317-2327 [3]Mease PJ. Ann. Rheum. Dis. 2020;79(1):123-131 [4]Berman J. Biologics . 2021 Nov 18;15:463-470 Disclosure of Interests Julie Birt Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, William Tillett Speakers bureau: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, MSD, Novartis,, Pfizer, UCB, Consultant of: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, UCB, Cristi Cavanaugh: None declared, Yoojin Jung: None declared, Aisha Vadhariya Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Sarah Ross Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Jess Paulus: None declared, Aubrey Trevelin Sprabery Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Ennio Lubrano: None declared